metastatic breast cancer
Conditions
Interventions
Pharmaceutical Form: Tablet
Other descriptive name: CAPECITABINE
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 150-500
Pharmaceutical Form: Tablet
INN or Propose
Sponsors
NKI-AVL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent. 2. Proven infiltrating breast cancer with distant metastases or inoperable locally advanced disease. 3. Positive estrogen receptor (= 10% positive nuclei at immunohistochemistry). Progesteron and HER-2 neu receptor have to be known. 4. - Progressive disease during first line hormonal therapy (either tamoxifen or aromatase inhibitor) for metastatic or inoperable locally advanced disease. Simultaneous use of LH-RH analogs is allowed. OR - Recurrence of disease (M1) during adjuvant hormonal therapy (either tamoxifen or aromatase inhibitor). 5. Non-measurable M1 disease is accepted. 6. Performance status: WHO 0 - 2. 7. Adequate bone marrow function (WBC count > 3.0 x 109/l, platelets > 100 x 109/l). 8. Adequate hepatic function (ALAT, ASAT and bilirubine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior chemotherapy for metastatic disease 2. Other malignancy except carcinoma in situ, unless the other malignancy was treated 5 or more years ago with curative intent without the use of chemotherapy or radiation therapy. 3. Pregnancy or breast feeding must be excluded and patients must use adequate contraceptive protection. 4. Eligibly for any other ongoing clinical trial in the NKI-AVL (this study has ‘posteriority’). 5. Contra-indications to the use of capecitabine (at the discretion of the treating physician)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary endpoints : Quality of life during the study period - Physical functioning scale of the QLQ-C30 - Global Health status/QoL of the QLQ-C30 ;Secondary Objective: Secondary endpoints: The EQ-5D Health State Summary Score The EQ-5D VAS Score Time to second progression and quality of life adjusted time to 2nd recurrence. Time to progression after first intervention. Overall survival ;Primary end point(s): This trial studies the effects on quality of life and on time to second progression of the sequence endocrine therapy-capecitabine versus the sequence capecitabine-endocrine treatment. It is anticipated that the time on study (which is the time between randomization and the discontinuation of the second treatment in the sequence) will be similar for both arms of the study. The quality of life during this period, however, could be better in the patient group receiving the most effective first agent in the sequence. If this proves to be true, the conventional wisdom that endocrine therapy should be continued until no further endocrine options remain, must be abandoned. | — |
Countries
Netherlands
Outcome results
None listed